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    Clinical Trial Results:
    A Phase 1/2a Study of BMS-986179 Administered Alone and in Combination with Nivolumab (BMS-936558) in Subjects with Advanced Solid Tumors

    Summary
    EudraCT number
    		 2016-000603-91
    Trial protocol
    		 NL   DE   IT  
    Global end of trial date
    12 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Oct 2022
    First version publication date
    28 Oct 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CA013-004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02754141
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Jun 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the safety and tolerability of BMS-986179 administered alone and in combination with nivolumab.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Jun 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 75
    Country: Number of subjects enrolled
    Australia: 8
    Country: Number of subjects enrolled
    Canada: 40
    Country: Number of subjects enrolled
    United States: 71
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Italy: 18
    Country: Number of subjects enrolled
    Netherlands: 18
    Worldwide total number of subjects
    235
    EEA total number of subjects
    116
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    140
    From 65 to 84 years
    94
    85 years and over
    1

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 235 participants treated

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 P1A 150mg
    Arm description
    		 BMS-986179 150mg monotherapy leading into BMS-986179 150mg + Nivo 240 combo therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P1A 300mg
    Arm description
    		 BMS-986179 300mg monotherapy leading into BMS-986179 300mg + Nivo 240mg combo therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    nivolmulab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Arm title
    		 P1A 600mg
    Arm description
    		 BMS-986179 600mg monotherapy leading into BMS-986179 600mg + Nivo 240mg combo therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    nivolmulab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Arm title
    		 P1A 1200mg
    Arm description
    		 BMS-986179 1200mg monotherapy leading into BMS-986179 1200mg + Nivo 240mg combo therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolmulab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P1A 1600mg
    Arm description
    		 BMS-986179 1600mg monotherapy leading into BMS-986179 1600mg + Nivo 240mg combo therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolmulab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P1B Combo Therapy 150mg
    Arm description
    		 BMS-986179 150mg + Nivo 360mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg
    Arm description
    		 BMS-986179 1200mg + Nivo 360mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
    Arm description
    		 BMS-986179 1200mg + Nivo 480mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P1B BMS986-179 1600mg
    Arm description
    		 BMS-986179 1600mg SC
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Arm title
    		 P2 Combo Pancreatic
    Arm description
    		 BMS-986179 1200mg Q2W + Nivo 240mg Q2W
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolmulab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P2 Combo Therapy NSCLC
    Arm description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolmulab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P2 Combo Melanoma
    Arm description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P2 Combo SCCHN
    Arm description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolmulab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P2 RCC Monotherapy
    Arm description
    		 BMS-986179 600mg Q2W monotherapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Arm title
    		 P2 RCC Combo Therapy
    Arm description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W combo therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolmulab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P2 Combo Prostate
    Arm description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P2 Combo Unassiged
    Arm description
    		 BMS-986179 1200mg Q2W + Nivo 240mg Q2W
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolmulab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P2 Monotherapy Unassigned
    Arm description
    		 BMS-986179 600mg Q2W
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Number of subjects in period 1
    		P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 RCC Monotherapy P2 RCC Combo Therapy P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned
    Started
    14
    12
    12
    9
    12
    9
    8
    7
    18
    19
    31
    15
    15
    19
    18
    14
    2
    1
    Continuing to Combo Therapy
    12
    11
    12
    7
    10
    0
    0
    0
    0 [1]
    0 [2]
    0 [3]
    0 [4]
    0 [5]
    0 [6]
    0 [7]
    0
    0 [8]
    0
    Crossing over to RCC combo therapy
    0 [9]
    0 [10]
    0 [11]
    0 [12]
    0 [13]
    0
    0
    0
    0 [14]
    0 [15]
    0 [16]
    0 [17]
    0 [18]
    3 [19]
    0 [20]
    0
    0 [21]
    0
    Completed
    1
    2
    4
    1
    2
    0
    0
    0
    6
    2
    11
    1
    1
    5
    5
    0
    2
    0
    Not completed
    13
    10
    8
    8
    10
    9
    8
    7
    12
    17
    20
    14
    14
    14
    13
    14
    0
    1
         Disease progression
    11
    7
    8
    5
    7
    7
    7
    6
    11
    16
    18
    13
    10
    12
    12
    14
    -
    1
         Study drug toxicity
    1
    1
    -
    -
    -
    -
    -
    -
    -
    -
    2
    1
    1
    -
    -
    -
    -
    -
         Request to discontinue
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    1
    1
    -
    -
    -
         Maximum clinical benefit
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         AE unrelated to study drug
    1
    1
    -
    1
    3
    2
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         No longer meets study criteria
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Other reasons
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    2
    -
    -
    -
    -
    -
         Withdrew consent
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
         Completed treatment as per protocol
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
         Not completing monotherapy
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [9] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [10] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [11] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [12] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [13] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [14] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [15] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [16] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [17] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [18] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [19] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [20] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [21] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    P1A 150mg
    Reporting group description
    		 BMS-986179 150mg monotherapy leading into BMS-986179 150mg + Nivo 240 combo therapy

    Reporting group title
    P1A 300mg
    Reporting group description
    		 BMS-986179 300mg monotherapy leading into BMS-986179 300mg + Nivo 240mg combo therapy

    Reporting group title
    P1A 600mg
    Reporting group description
    		 BMS-986179 600mg monotherapy leading into BMS-986179 600mg + Nivo 240mg combo therapy

    Reporting group title
    P1A 1200mg
    Reporting group description
    		 BMS-986179 1200mg monotherapy leading into BMS-986179 1200mg + Nivo 240mg combo therapy

    Reporting group title
    P1A 1600mg
    Reporting group description
    		 BMS-986179 1600mg monotherapy leading into BMS-986179 1600mg + Nivo 240mg combo therapy

    Reporting group title
    P1B Combo Therapy 150mg
    Reporting group description
    		 BMS-986179 150mg + Nivo 360mg

    Reporting group title
    P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg
    Reporting group description
    		 BMS-986179 1200mg + Nivo 360mg

    Reporting group title
    P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
    Reporting group description
    		 BMS-986179 1200mg + Nivo 480mg

    Reporting group title
    P1B BMS986-179 1600mg
    Reporting group description
    		 BMS-986179 1600mg SC

    Reporting group title
    P2 Combo Pancreatic
    Reporting group description
    		 BMS-986179 1200mg Q2W + Nivo 240mg Q2W

    Reporting group title
    P2 Combo Therapy NSCLC
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 Combo Melanoma
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 Combo SCCHN
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 RCC Monotherapy
    Reporting group description
    		 BMS-986179 600mg Q2W monotherapy

    Reporting group title
    P2 RCC Combo Therapy
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W combo therapy

    Reporting group title
    P2 Combo Prostate
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 Combo Unassiged
    Reporting group description
    		 BMS-986179 1200mg Q2W + Nivo 240mg Q2W

    Reporting group title
    P2 Monotherapy Unassigned
    Reporting group description
    		 BMS-986179 600mg Q2W

    Reporting group values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 RCC Monotherapy P2 RCC Combo Therapy P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned Total
    Number of subjects
    		 14 12 12 9 12 9 8 7 18 19 31 15 15 19 18 14 2 1 235
    Age Categorical
    Units: Participants
        <=18 years
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Between 18 and 65 years
    		 7 9 10 5 7 5 7 5 11 14 14 8 6 12 12 5 2 1 140
        >=65 years
    		 7 3 2 4 5 4 1 2 7 5 17 7 9 7 6 9 0 0 95
    Sex: Female, Male
    Units: Participants
        Female
    		 8 5 2 3 7 7 4 2 10 8 10 9 1 13 13 0 0 0 102
        Male
    		 6 7 10 6 5 2 4 5 8 11 21 6 14 6 5 14 2 1 133
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Asian
    		 0 1 1 0 0 0 0 1 3 0 0 0 1 0 0 1 0 0 8
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Black or African American
    		 0 0 0 1 0 1 1 0 0 0 1 0 0 1 0 0 0 5
        White
    		 14 11 10 8 12 8 7 5 14 19 30 15 14 18 18 13 1 1 218
        More than one race
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 1 0 0 0 0 1 1 0 0 0 0 0 0 0 1 0 4
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 2
        Not Hispanic or Latino
    		 5 4 6 4 5 4 3 7 11 11 1 3 2 12 12 0 2 0 92
        Unknown or Not Reported
    		 9 7 6 5 7 5 5 0 7 8 30 12 12 7 6 14 0 1 141
    Subject analysis sets

    Subject analysis set title
    P2 RCC Combo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 600mg Q2W + Nivo 480mg Q4W combo therapy

    Subject analysis set title
    P1A Combo Therapy 150mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 150mg + Nivo 240mg

    Subject analysis set title
    P1A Combo Therapy 300mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 300mg + Nivo 240mg

    Subject analysis set title
    P1A Combo Therapy 600mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 600mg + Nivo 240mg

    Subject analysis set title
    P1A Combo Therapy 1200mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 1200mg + Nivo 240mg

    Subject analysis set title
    P1A Combo Therapy 1600mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 1600mg + Nivo 240mg

    Subject analysis set title
    P2 Combo RCC Crossover
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Subject analysis sets values
    		 P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects
    18
    12
    11
    12
    7
    10
    3
    Age Categorical
    Units: Participants
        <=18 years
    0
        Between 18 and 65 years
    12
        >=65 years
    6
    Age continuous
    Units:
        
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    Sex: Female, Male
    Units: Participants
        Female
    5
        Male
    13
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0
        Asian
    0
        Native Hawaiian or Other Pacific Islander
    0
        Black or African American
    0
        White
    18
        More than one race
    0
        Unknown or Not Reported
    0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    0
        Not Hispanic or Latino
    12
        Unknown or Not Reported
    6

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    P1A 150mg
    Reporting group description
    		 BMS-986179 150mg monotherapy leading into BMS-986179 150mg + Nivo 240 combo therapy

    Reporting group title
    P1A 300mg
    Reporting group description
    		 BMS-986179 300mg monotherapy leading into BMS-986179 300mg + Nivo 240mg combo therapy

    Reporting group title
    P1A 600mg
    Reporting group description
    		 BMS-986179 600mg monotherapy leading into BMS-986179 600mg + Nivo 240mg combo therapy

    Reporting group title
    P1A 1200mg
    Reporting group description
    		 BMS-986179 1200mg monotherapy leading into BMS-986179 1200mg + Nivo 240mg combo therapy

    Reporting group title
    P1A 1600mg
    Reporting group description
    		 BMS-986179 1600mg monotherapy leading into BMS-986179 1600mg + Nivo 240mg combo therapy

    Reporting group title
    P1B Combo Therapy 150mg
    Reporting group description
    		 BMS-986179 150mg + Nivo 360mg

    Reporting group title
    P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg
    Reporting group description
    		 BMS-986179 1200mg + Nivo 360mg

    Reporting group title
    P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
    Reporting group description
    		 BMS-986179 1200mg + Nivo 480mg

    Reporting group title
    P1B BMS986-179 1600mg
    Reporting group description
    		 BMS-986179 1600mg SC

    Reporting group title
    P2 Combo Pancreatic
    Reporting group description
    		 BMS-986179 1200mg Q2W + Nivo 240mg Q2W

    Reporting group title
    P2 Combo Therapy NSCLC
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 Combo Melanoma
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 Combo SCCHN
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 RCC Monotherapy
    Reporting group description
    		 BMS-986179 600mg Q2W monotherapy

    Reporting group title
    P2 RCC Combo Therapy
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W combo therapy

    Reporting group title
    P2 Combo Prostate
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 Combo Unassiged
    Reporting group description
    		 BMS-986179 1200mg Q2W + Nivo 240mg Q2W

    Reporting group title
    P2 Monotherapy Unassigned
    Reporting group description
    		 BMS-986179 600mg Q2W

    Subject analysis set title
    P2 RCC Combo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 600mg Q2W + Nivo 480mg Q4W combo therapy

    Subject analysis set title
    P1A Combo Therapy 150mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 150mg + Nivo 240mg

    Subject analysis set title
    P1A Combo Therapy 300mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 300mg + Nivo 240mg

    Subject analysis set title
    P1A Combo Therapy 600mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 600mg + Nivo 240mg

    Subject analysis set title
    P1A Combo Therapy 1200mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 1200mg + Nivo 240mg

    Subject analysis set title
    P1A Combo Therapy 1600mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 1600mg + Nivo 240mg

    Subject analysis set title
    P2 Combo RCC Crossover
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Primary: Number of participants with drug related AEs, SAEs, AEs leading to discontinuation and deaths.

    		 Close Top of page
    End point title
    		 Number of participants with drug related AEs, SAEs, AEs leading to discontinuation and deaths. [1] [2]
    End point description
    Number of participants with drug related adverse events (AE), drug related serious adverse events (SAE), drug related AEs Leading to discontinuation and drug related deaths
    End point type
    Primary
    End point timeframe
    From first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No subjects analyzed for this arm
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects analysed
    14
    12
    12
    9
    12
    9
    8
    7
    18
    19
    31
    15
    15
    14
    2
    1
    18
    12
    11
    12
    7
    10
    3
    Units: Participants
        Adverse Events
    7
    4
    3
    4
    5
    5
    1
    2
    4
    11
    21
    7
    12
    8
    1
    0
    15
    7
    7
    6
    5
    7
    3
        Serious Adverse Events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    1
    2
    0
    1
    0
    1
    0
        AEs Leading to Discontinuation
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    1
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
        Deaths
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with a best overall response (BOR) at week 24

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    End point title
    		 Number of participants with a best overall response (BOR) at week 24 [3]
    End point description
    Best overall response (BOR) is defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. CR or PR determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met.
    End point type
    Secondary
    End point timeframe
    from initial treatment to week 24
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects analysed
    14
    12
    12
    9
    12
    9
    8
    7
    18
    19
    31
    15
    15
    14
    2
    1
    18
    12
    11
    12
    7
    10
    3
    Units: Participants
        Complete Response
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Partial Response
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
    1
    1
    2
    1
    1
    0
    No statistical analyses for this end point

    Secondary: Percentage of participants with an objective response rate (ORR) at week 24

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    End point title
    		 Percentage of participants with an objective response rate (ORR) at week 24 [4]
    End point description
    ORR is defined as the percentage of all treated participants whose BOR is either a CR or PR. Here "99999 and -99999" means not available
    End point type
    Secondary
    End point timeframe
    from initial treatment to week 24
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects analysed
    14
    12
    12
    9
    12
    9
    8
    7
    18
    19
    31
    15
    15
    14
    2
    1
    18
    12
    11
    12
    7
    10
    3
    Units: Percentage of Participants
        number (confidence interval 95%)
    0 (0.0 to 84.2)
    0 (0.0 to 97.5)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (0.0 to 84.2)
    0 (0.0 to 33.6)
    0 (0.0 to 36.9)
    0 (0.0 to 41.0)
    0 (0.0 to 18.5)
    5.3 (0.1 to 26.0)
    3.2 (0.1 to 16.7)
    0 (0.0 to 21.8)
    13.3 (1.7 to 40.5)
    0 (0.0 to 23.2)
    0 (0.0 to 84.2)
    0 (0.0 to 97.5)
    0 (0.0 to 18.5)
    8.3 (0.2 to 38.5)
    9.1 (0.2 to 41.3)
    16.7 (2.1 to 48.4)
    14.3 (0.4 to 57.9)
    10.0 (0.3 to 44.5)
    0 (0.0 to 70.8)
    No statistical analyses for this end point

    Secondary: Progression free survival rate (PFSR) at week 24

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    End point title
    		 Progression free survival rate (PFSR) at week 24 [5]
    End point description
    PFSR at 24 weeks is defined as the percentage of treated participants remaining progression free and surviving at 24 weeks. Here "99999 and -99999" means not available
    End point type
    Secondary
    End point timeframe
    from initial treatment to week 24
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects analysed
    14
    12
    12
    9
    12
    9
    8
    7
    18
    19
    31
    15
    15
    14
    2
    1
    18
    12
    11
    12
    7
    10
    3
    Units: Percentage
        number (confidence interval 95%)
    7.1 (1.3 to 98.7)
    8.3 (2.5 to 100.0)
    0 (-99999 to 99999)
    11.1 (1.3 to 98.7)
    16.7 (15.8 to 100.0)
    88.9 (51.8 to 99.7)
    87.5 (47.3 to 99.7)
    100.00 (59.0 to 100.0)
    88.9 (65.3 to 98.6)
    94.7 (74.0 to 99.9)
    71.0 (52.0 to 85.8)
    86.7 (59.5 to 98.3)
    80.0 (51.9 to 95.7)
    71.4 (41.9 to 91.6)
    50.0 (1.3 to 98.7)
    100.0 (2.5 to 100.0)
    72.2 (46.5 to 90.3)
    83.3 (51.6 to 97.9)
    72.7 (39.0 to 94.0)
    75.0 (42.8 to 94.5)
    57.1 (18.4 to 90.1)
    70.0 (34.8 to 93.3)
    66.7 (9.4 to 99.2)
    No statistical analyses for this end point

    Secondary: Median duration of response (DOR)

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    End point title
    		 Median duration of response (DOR) [6]
    End point description
    DOR (computed for all treated subjects with a BOR of CR or PR) is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first. Here "99999 and -99999" means not available
    End point type
    Secondary
    End point timeframe
    from first measure response approximately up to 25 months
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects analysed
    14
    12
    12
    9
    12
    9
    8
    7
    18
    19
    31
    15
    15
    14
    2
    1
    18
    12
    11
    12
    7
    10
    3
    Units: Months
        median (full range (min-max))
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    3.90 (3.9 to 3.9)
    3.80 (3.8 to 3.8)
    99999 (-99999 to 99999)
    6.70 (3.8 to 9.6)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    17.40 (17.4 to 17.4)
    5.70 (5.7 to 5.7)
    9.30 (7.2 to 11.4)
    2.10 (2.1 to 2.1)
    24.40 (24.4 to 24.4)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Cmax

    		 Close Top of page
    End point title
    		 Cmax [7]
    End point description
    Cmax is defined as maximum plasma concentration of the drug Here "99999 and -99999" means not available
    End point type
    Secondary
    End point timeframe
    Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects analysed
    14
    12
    0 [8]
    9
    12
    0 [9]
    0 [10]
    0 [11]
    18
    0 [12]
    0 [13]
    0 [14]
    0 [15]
    0 [16]
    0 [17]
    0 [18]
    0 [19]
    12
    11
    12
    7
    10
    0 [20]
    Units: ug/mL
    geometric mean (geometric coefficient of variation)
        Cycle 0 Day 1
    30.6524 ± 66
    94.9210 ± 99999
    ±
    218.0423 ± 8
    499.5178 ± 10
    ±
    ±
    ±
    99999 ± 99999
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    28.8892 ± 25
    64.3400 ± 55
    141.3732 ± 26
    315.6963 ± 16
    453.5664 ± 27
    ±
        Cycle 1 Day 1
    99999 ± 99999
    9999999999 ± 99999
    ±
    99999 ± 99999
    99999 ± 99999
    ±
    ±
    ±
    93.7415 ± 33
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    ±
        Cycle 1 Day 22
    99999 ± 99999
    99999 ± 99999
    ±
    99999 ± 99999
    99999 ± 99999
    ±
    ±
    ±
    99999 ± 99999
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    51.3637 ± 38
    99.3564 ± 47
    289.8829 ± 27
    722.2768 ± 32
    865.8497 ± 22
    ±
        Cycle 2 Day 1
    99999 ± 99999
    99999 ± 99999
    ±
    99999 ± 99999
    99999 ± 99999
    ±
    ±
    ±
    563.4487 ± 27
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    ±
        cycle 4 Day 15
    99999 ± 99999
    99999 ± 99999
    ±
    99999 ± 99999
    99999 ± 99999
    ±
    ±
    ±
    99999 ± 99999
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    ±
    Notes
    [8] - No subjects analyzed
    [9] - No subjects analyzed
    [10] - No subjects analyzed
    [11] - No subjects analyzed
    [12] - No subjects analyzed
    [13] - No subjects analyzed
    [14] - No subjects analyzed
    [15] - No subjects analyzed
    [16] - No subjects analyzed
    [17] - No subjects analyzed
    [18] - No subjects analyzed
    [19] - No subjects analyzed
    [20] - No subjects analyzed
    No statistical analyses for this end point

    Secondary: Tmax

    		 Close Top of page
    End point title
    		 Tmax [21]
    End point description
    Tmax is defined is the time to maximum plasma concentration Here "99999 and -99999" means not available
    End point type
    Secondary
    End point timeframe
    Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects analysed
    14
    12
    0 [22]
    9
    12
    0 [23]
    0 [24]
    0 [25]
    18
    0 [26]
    0 [27]
    0 [28]
    0 [29]
    0 [30]
    0 [31]
    0 [32]
    0 [33]
    12
    11
    12
    7
    10
    0 [34]
    Units: hours
    median (full range (min-max))
        Cycle 0 Day 1
    2.409 (0.800 to 4.017)
    0.933 (0.933 to 0.933)
    ( to )
    2.992 (1.983 to 4.00)
    2.700 (2.400 to 3.00)
    ( to )
    ( to )
    ( to )
    99999 (99999 to 99999)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    1.00 (0.967 to 8.250)
    2.942 (0.967 to 8.00)
    1.109 (0.867 to 24.050)
    4.000 (1.967 to 8.000)
    3.692 (1.783 to 24.117)
    ( to )
        Cycle 1 Day 1
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    ( to )
    ( to )
    96.200 (48.017 to 168.267)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
        Cycle 1 Day 22
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    ( to )
    ( to )
    99999 (99999 to 99999)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    4.000 (0.967 to 9.050)
    7.767 (4.067 to 95.950)
    4.000 (0.967 to 7.933)
    8.000 (2.100 to 10.050)
    4.000 (1.983 to 8.000)
    ( to )
        Cycle 2 Day 1
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    ( to )
    ( to )
    4.000 (1.967 to 24.667)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
        cycle 4 Day 15
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    ( to )
    ( to )
    99999 (99999 to 99999)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    Notes
    [22] - no subjects analyzed
    [23] - no subjects analyzed
    [24] - no subjects analyzed
    [25] - no subjects analyzed
    [26] - no subjects analyzed
    [27] - no subjects analyzed
    [28] - no subjects analyzed
    [29] - no subjects analyzed
    [30] - no subjects analyzed
    [31] - no subjects analyzed
    [32] - no subjects analyzed
    [33] - no subjects analyzed
    [34] - no subjects analyzed
    No statistical analyses for this end point

    Secondary: AUC (0-T)

    		 Close Top of page
    End point title
    		 AUC (0-T) [35]
    End point description
    Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration Here "99999 and -99999" means not available
    End point type
    Secondary
    End point timeframe
    Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
    Notes
    [35] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects analysed
    14
    12
    0 [36]
    9
    12
    0 [37]
    0 [38]
    0 [39]
    18
    0 [40]
    0 [41]
    0 [42]
    0 [43]
    0 [44]
    0 [45]
    0 [46]
    0 [47]
    12
    11
    12
    7
    10
    0 [48]
    Units: h*ug/mL
    geometric mean (geometric coefficient of variation)
        Cycle 0 Day 1
    1414.4834 ± 76
    2565.0489 ± 99999
    ±
    9362.9155 ± 39
    30716.0037 ± 47
    ±
    ±
    ±
    99999 ± 99999
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    1225.3679 ± 36
    3418.8393 ± 62
    9139.4853 ± 30
    23533.0706 ± 9
    31057.8588 ± 26
    ±
        Cycle 1 Day 1
    99999 ± 99999
    99999 ± 99999
    ±
    99999 ± 99999
    99999 ± 99999
    ±
    ±
    ±
    41672.2787 ± 35
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    ±
        Cycle 1 Day 22
    99999 ± 99999
    99999 ± 99999
    ±
    99999 ± 99999
    99999 ± 99999
    ±
    ±
    ±
    99999 ± 99999
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    3932.5889 ± 44
    9622.5237 ± 58
    27616.4807 ± 40
    74405.3428 ± 25
    92340.2959 ± 21
    ±
        Cycle 2 Day 1
    99999 ± 99999
    99999 ± 99999
    ±
    99999 ± 99999
    99999 ± 99999
    ±
    ±
    ±
    84384.9379 ± 36
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    ±
        cycle 4 Day 15
    99999 ± 99999
    99999 ± 99999
    ±
    99999 ± 99999
    99999 ± 99999
    ±
    ±
    ±
    99999 ± 99999
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    ±
    Notes
    [36] - no subjects analyzed
    [37] - no subjects analyzed
    [38] - no subjects analyzed
    [39] - no subjects analyzed
    [40] - no subjects analyzed
    [41] - no subjects analyzed
    [42] - no subjects analyzed
    [43] - no subjects analyzed
    [44] - no subjects analyzed
    [45] - no subjects analyzed
    [46] - no subjects analyzed
    [47] - no subjects analyzed
    [48] - no subjects analyzed
    No statistical analyses for this end point

    Secondary: AUC (Tau)

    		 Close Top of page
    End point title
    		 AUC (Tau) [49]
    End point description
    Area under the plasma concentration time-curve. AUC over the dosing interval. Here "99999 and -99999" means not available
    End point type
    Secondary
    End point timeframe
    Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
    Notes
    [49] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects analysed
    14
    0 [50]
    0 [51]
    0 [52]
    12
    0 [53]
    0 [54]
    0 [55]
    18
    0 [56]
    0 [57]
    0 [58]
    0 [59]
    0 [60]
    0 [61]
    0 [62]
    0 [63]
    12
    11
    12
    7
    10
    0 [64]
    Units: h*ug/mL
    geometric mean (geometric coefficient of variation)
        Cycle 0 Day 1
    1417.4834 ± 76
    ±
    ±
    ±
    34198.6293 ± 33
    ±
    ±
    ±
    99999 ± 99999
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    1307.7132 ± 33
    3546.1659 ± 59
    9139.4853 ± 30
    23533.0706 ± 9
    34970.3626 ± 12
    ±
        Cycle 1 Day 1
    99999 ± 99999
    ±
    ±
    ±
    99999 ± 99999
    ±
    ±
    ±
    40833.1977 ± 36
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    ±
        Cycle 1 Day 22
    99999 ± 99999
    ±
    ±
    ±
    99999 ± 99999
    ±
    ±
    ±
    99999 ± 99999
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    3975.0900 ± 46
    12326.2351 ± 44
    30044.3813 ± 35
    74405.3428 ± 25
    92340.2959 ± 21
    ±
        Cycle 2 Day 1
    99999 ± 99999
    ±
    ±
    ±
    99999 ± 99999
    ±
    ±
    ±
    92770.2634 ± 30
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    ±
        cycle 4 Day 15
    99999 ± 99999
    ±
    ±
    ±
    99999 ± 99999
    ±
    ±
    ±
    99999 ± 99999
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    ±
    Notes
    [50] - No subjects analyzed
    [51] - No subjects analyzed
    [52] - No subjects analyzed
    [53] - No subjects analyzed
    [54] - No subjects analyzed
    [55] - No subjects analyzed
    [56] - No subjects analyzed
    [57] - No subjects analyzed
    [58] - No subjects analyzed
    [59] - No subjects analyzed
    [60] - No subjects analyzed
    [61] - No subjects analyzed
    [62] - No subjects analyzed
    [63] - No subjects analyzed
    [64] - No subjects analyzed
    No statistical analyses for this end point

    Secondary: Ctau

    		 Close Top of page
    End point title
    		 Ctau [65]
    End point description
    Ctau is defined as the concentration of study drug at the end of the dosing interval. Here "99999 and -99999" means not available
    End point type
    Secondary
    End point timeframe
    Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
    Notes
    [65] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects analysed
    14
    0 [66]
    0 [67]
    0 [68]
    12
    0 [69]
    0 [70]
    0 [71]
    18
    0 [72]
    0 [73]
    0 [74]
    0 [75]
    0 [76]
    0 [77]
    0 [78]
    0 [79]
    12
    11
    12
    7
    10
    0 [80]
    Units: h*ug/mL
    geometric mean (geometric coefficient of variation)
        Cycle 0 Day 1
    1.9173 ± 99
    ±
    ±
    ±
    82.2225 ± 82
    ±
    ±
    ±
    99999 ± 99999
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    0.8999 ± 74
    5.4691 ± 59
    25.9755 ± 32
    74.8859 ± 30
    99.0307 ± 14
    ±
        Cycle 1 Day 1
    99999 ± 99999
    ±
    ±
    ±
    99999 ± 99999
    ±
    ±
    ±
    30.0008 ± 51
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    ±
        Cycle 1 Day 22
    99999 ± 99999
    ±
    ±
    ±
    99999 ± 99999
    ±
    ±
    ±
    99999 ± 99999
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    14.5545 ± 54
    51.0567 ± 44
    126.4960 ± 37
    366.8165 ± 21
    466.5231 ± 32
    ±
        Cycle 2 Day 1
    99999 ± 99999
    ±
    ±
    ±
    99999 ± 99999
    ±
    ±
    ±
    52.9049 ± 71
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    ±
        cycle 4 Day 15
    99999 ± 99999
    ±
    ±
    ±
    99999 ± 99999
    ±
    ±
    ±
    99999 ± 99999
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    ±
    Notes
    [66] - No Subjects Analyzed
    [67] - No Subjects Analyzed
    [68] - No Subjects Analyzed
    [69] - No Subjects Analyzed
    [70] - No Subjects Analyzed
    [71] - No Subjects Analyzed
    [72] - No Subjects Analyzed
    [73] - No Subjects Analyzed
    [74] - No Subjects Analyzed
    [75] - No Subjects Analyzed
    [76] - No Subjects Analyzed
    [77] - No Subjects Analyzed
    [78] - No Subjects Analyzed
    [79] - No Subjects Analyzed
    [80] - No Subjects Analyzed
    No statistical analyses for this end point

    Secondary: Mean change from baseline in CD73 assays

    		 Close Top of page
    End point title
    		 Mean change from baseline in CD73 assays [81]
    End point description
    Mean change from baseline in CD73 assays at the end of Part 1A treatment period Assays Measured: EHC CD73 H-score IHC CD73 Cytoplasm H-Score IHC CDS73 Membrane H-Score Here "99999 and -99999" means not available
    End point type
    Secondary
    End point timeframe
    approximately up to 95 weeks
    Notes
    [81] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects analysed
    14
    12
    0 [82]
    9
    12
    0 [83]
    0 [84]
    0 [85]
    0 [86]
    0 [87]
    0 [88]
    0 [89]
    0 [90]
    0 [91]
    0 [92]
    0 [93]
    0 [94]
    12
    11
    0 [95]
    7
    10
    0 [96]
    Units: mean change from baseline
    arithmetic mean (standard error)
        EHC CD73 H-Score
    -33.790 ± 25.5200
    -103.700 ± 90.3400
    ±
    -204.710 ± 99999
    -3.220 ± 51.7800
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    -33.790 ± 28.5200
    -103.700 ± 90.3400
    ±
    -204.710 ± 99999
    -3.220 ± 51.7800
    ±
        IHC CD73 Cytoplasm H-Score
    1.5 ± 2.60
    -0.3 ± 32.04
    ±
    17.0 ± 99999
    0.0 ± 0.00
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    1.5 ± 2.60
    -0.3 ± 32.04
    ±
    17.0 ± 99999
    0.0 ± 0.00
    ±
        IHC CD73 Membrane H-Score
    7.3 ± 6.77
    8.7 ± 30.33
    ±
    88.0 ± 99999
    0.00 ± 0.00
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    7.3 ± 6.77
    8.7 ± 30.33
    ±
    88.0 ± 99999
    0.0 ± 0.00
    ±
    Notes
    [82] - No subjects analyzed
    [83] - No subjects analyzed
    [84] - No subjects analyzed
    [85] - No subjects analyzed
    [86] - No subjects analyzed
    [87] - No subjects analyzed
    [88] - No subjects analyzed
    [89] - No subjects analyzed
    [90] - No subjects analyzed
    [91] - No subjects analyzed
    [92] - No subjects analyzed
    [93] - No subjects analyzed
    [94] - No subjects analyzed
    [95] - No subjects analyzed
    [96] - No subjects analyzed
    No statistical analyses for this end point

    Secondary: Number of participants with a positive anti-drug antibody (ADA) test.

    		 Close Top of page
    End point title
    		 Number of participants with a positive anti-drug antibody (ADA) test. [97]
    End point description
    A participant with at least one ADA-positive sample relative to baseline at any time after initiation of treatment with BMS-986179 and nivolumab.
    End point type
    Secondary
    End point timeframe
    From first dose to last dose: Part 1: up to 95 weeks, Part 2 SC: up to 62 weeks, RCC Mono: up to 108 weeks, Part 2: up to 104 weeks
    Notes
    [97] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P2 Combo RCC Crossover
    Number of subjects analysed
    14
    12
    12
    9
    12
    9
    8
    7
    18
    19
    31
    15
    15
    14
    2
    1
    18
    3
    Units: Participants
        BMS-986179 ADA+
    5
    4
    8
    3
    2
    5
    6
    5
    11
    9
    22
    9
    6
    8
    1
    0
    14
    2
        Nivolumab ADA+
    0
    1
    0
    0
    0
    1
    1
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
    Adverse event reporting additional description
    Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose:
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    P1A BMS1200
    Reporting group description
    		 BMS-986179 1200mg monotherapy

    Reporting group title
    P1A BMS150
    Reporting group description
    		 BMS-986179 150mg monotherapy

    Reporting group title
    P1A BMS300
    Reporting group description
    		 BMS-986179 300mg monotherapy

    Reporting group title
    P1A BMS600
    Reporting group description
    		 BMS-986179 600mg monotherapy

    Reporting group title
    P1A BMS600+NIV240
    Reporting group description
    		 BMS-986179 600mg + Nivo 240mg

    Reporting group title
    P1A BMS300+NIV240
    Reporting group description
    		 BMS-986179 3000mg + Nivo 240mg

    Reporting group title
    P1A BMS150+NIV240
    Reporting group description
    		 BMS-986179 150mg + Nivo 240mg

    Reporting group title
    P1A ALL MONO
    Reporting group description
    		 P1A all treated participants in monotherapy

    Reporting group title
    P1A BMS1200+NIV240
    Reporting group description
    		 BMS-986179 1200mg + Nivo 240mg

    Reporting group title
    P1A BMS1600
    Reporting group description
    		 BMS-986179 1600mg monotherapy

    Reporting group title
    P1B BMS1200+NIV360
    Reporting group description
    		 BMS-986179 1200mg + Nivo360mg

    Reporting group title
    P1B BMS150+NIV360
    Reporting group description
    		 BMS-986179 150mg + Nivo 360mg

    Reporting group title
    P1A ALL COMBO
    Reporting group description
    		 P1A all treated participants in combo therapy

    Reporting group title
    P1A BMS1600+NIV240
    Reporting group description
    		 BMS-986179 1600mg + Nivo 240mg

    Reporting group title
    P1B BMS1200+NIV480
    Reporting group description
    		 BMS-986179 1200mg + Nivo 480mg

    Reporting group title
    P1B BMS1600SC
    Reporting group description
    		 BMS-986179 1600mg SC

    Reporting group title
    P1B ALL COMBO
    Reporting group description
    		 All treated participants in P1B combo therapy period

    Reporting group title
    P2 PANCREATIC COMBO
    Reporting group description
    		 BMS-986179 1200mg Q2W + Nivo 240mg Q2W

    Reporting group title
    P2 NSCLC COMBO
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 MELANOMA COMBO
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 2 SCCHN COMBO
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 RCC COMBO
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 RCC MONO
    Reporting group description
    		 BMS-986179 600mg Q2W Monotherapy

    Reporting group title
    P2 RCC CROSSOVER
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 PROSTATE COMBO
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 NOT ASSIGNED MONO
    Reporting group description
    		 BMS-986179 600mg Q2W

    Reporting group title
    P2 NOT ASSIGNED COMBO
    Reporting group description
    		 BMS-986179 1200mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 ALL COMBO
    Reporting group description
    		 All Treated participants in the P2 treatment period

    Reporting group title
    ALL COMBO (P1A+P1B+P2)
    Reporting group description
    		 All treated participants in P1A, P1B and P2 combo therapy periods

    Serious adverse events
    		 P1A BMS1200 P1A BMS150 P1A BMS300 P1A BMS600 P1A BMS600+NIV240 P1A BMS300+NIV240 P1A BMS150+NIV240 P1A ALL MONO P1A BMS1200+NIV240 P1A BMS1600 P1B BMS1200+NIV360 P1B BMS150+NIV360 P1A ALL COMBO P1A BMS1600+NIV240 P1B BMS1200+NIV480 P1B BMS1600SC P1B ALL COMBO P2 PANCREATIC COMBO P2 NSCLC COMBO P2 MELANOMA COMBO P2 2 SCCHN COMBO P2 RCC COMBO P2 RCC MONO P2 RCC CROSSOVER P2 PROSTATE COMBO P2 NOT ASSIGNED MONO P2 NOT ASSIGNED COMBO P2 ALL COMBO ALL COMBO (P1A+P1B+P2)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 9 (22.22%)
    3 / 14 (21.43%)
    4 / 12 (33.33%)
    1 / 12 (8.33%)
    9 / 12 (75.00%)
    6 / 11 (54.55%)
    5 / 12 (41.67%)
    13 / 59 (22.03%)
    3 / 7 (42.86%)
    3 / 12 (25.00%)
    7 / 8 (87.50%)
    7 / 9 (77.78%)
    28 / 52 (53.85%)
    5 / 10 (50.00%)
    4 / 7 (57.14%)
    11 / 18 (61.11%)
    18 / 24 (75.00%)
    8 / 19 (42.11%)
    14 / 31 (45.16%)
    8 / 15 (53.33%)
    11 / 15 (73.33%)
    11 / 18 (61.11%)
    5 / 19 (26.32%)
    1 / 3 (33.33%)
    4 / 14 (28.57%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    57 / 117 (48.72%)
    103 / 193 (53.37%)
         number of deaths (all causes)
    2
    2
    1
    0
    11
    11
    9
    7
    6
    2
    8
    9
    45
    8
    5
    18
    22
    14
    23
    14
    13
    9
    8
    1
    13
    0
    1
    88
    155
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    1 / 9 (11.11%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    2 / 24 (8.33%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    3 / 193 (1.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant neoplasm progression
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    4 / 12 (33.33%)
    4 / 11 (36.36%)
    1 / 12 (8.33%)
    4 / 59 (6.78%)
    2 / 7 (28.57%)
    2 / 12 (16.67%)
    4 / 8 (50.00%)
    3 / 9 (33.33%)
    13 / 52 (25.00%)
    2 / 10 (20.00%)
    2 / 7 (28.57%)
    3 / 18 (16.67%)
    9 / 24 (37.50%)
    8 / 19 (42.11%)
    4 / 31 (12.90%)
    6 / 15 (40.00%)
    5 / 15 (33.33%)
    1 / 18 (5.56%)
    2 / 19 (10.53%)
    1 / 3 (33.33%)
    2 / 14 (14.29%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    27 / 117 (23.08%)
    49 / 193 (25.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 4
    0 / 4
    0 / 1
    0 / 4
    0 / 2
    0 / 2
    0 / 4
    0 / 3
    0 / 13
    0 / 2
    0 / 2
    0 / 3
    0 / 9
    0 / 8
    0 / 4
    0 / 6
    0 / 5
    0 / 1
    0 / 2
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 27
    0 / 49
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasm
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasm progression
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tumour associated fever
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tumour pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    4 / 31 (12.90%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    4 / 117 (3.42%)
    4 / 193 (2.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    3 / 193 (1.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Performance status decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    4 / 193 (2.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    1 / 59 (1.69%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    4 / 31 (12.90%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    6 / 117 (5.13%)
    8 / 193 (4.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngeal necrosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Adjustment disorder
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device malfunction
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver function test increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid artery dissection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident